The Rock Weekly

We’ve waited six years for the FDA’s latest guidance docs

The FDA admitted “regulatory ambiguity” is hampering technology innovation in healthcare. The agency released three guidance docs last week in an effort to clarify. Developers have waited six years for one: FDA will generally not regulate “clinical decision support tools that allow the provider to independently review the basis for the recommendations.” But some feel the agency didn’t go far enough. There was no mention of how they plan to regulate AI nor hint of adopting a risk-based approach, for example.

Meanwhile, FCC’s Ajit Pai says net neutrality will help telemedicine. But industry insiders shot back saying tiered access would create complications, especially for rural healthcare.

Recent Funding

  • New unicorn: HeartFlow raised $150M on $1.4B valuation to help doctors detect coronary artery disease
  • Fitness app Aaptiv raised $38M, boasting $20M in revenue
  • Cedar's intelligent patient billing platform draws $13M
  • SwipeSense received $10M for its sensing technology to stop bugs in hospitals